S.L. 458.34 ст. 3Applicability.

(1) The provisions of these regulations shall apply to medicinal products for human use intended to be placed on the market in Malta and either prepared industrially or manufactured by a method involving an industrial process.

(2) In cases of doubt, where, taking into account all its characteristics, a product may fall within the definition of a ''medicinal product'' and within the definition of a product covered by other community legislation, the provisions of these regulations shall apply.